Metformin impurity amount, theoretically 1/90 of Ranitidine
By Kim, Jin-Gu | translator Choi HeeYoung
19.12.10 06:20:46
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MFDS "Total calculated '1/90' level of Ranitidine as a result of toxicity calculation. Cause of creation requires overhaul , Overhaul required
Agilent reports show similar results, 'Ranithidine 90%, Nizatidine 5%, Metformin 1% or less'
¡ãMolecular structure of Metformin
With Metformin, issues of impurity detection have been raised, and it is possible that N-nitrosodimethylamine (NDMA) will be detected much less than earlier Ranitidine or Nizatidine.According to officials at the MFDS on Dec 9, a qualitative structure activity relationship (QSAR) is used as a simple test to determine the toxicity of a substance.
It is a test method that compares and predicts physical and chemical properties by similarity of intrinsic chemical structure. Since the properties of a substance are closely related to its molecular structure, it is a principle that similar physical structures have similar physical properties and toxicity.
In fact, the results of
Kim, Jin-Gu(kjg@dailypharm.com)
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